Medical slings

ABSTRACT

A sling in accordance with the invention includes a synthetic material and a non-synthetic material positioned adjacent thereto. The non-synthetic material may be wrapped around or may be attached to the synthetic material. Additionally, the non-synthetic material may include slits. Methods for making such slings are also described.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 09/916,983, filed on Jul. 27, 2001 now U.S. Pat. No. 6,755,781,and incorporates by reference, and claims priority to and the benefitof, provisional U.S. patent application Ser. No. 60/388,109, filed onJun. 12, 2002.

TECHNICAL FIELD

This invention generally relates to medical slings, methods of makingsuch slings, kits including such slings, and methods of treating adamaged portion of a patient's body using such slings.

BACKGROUND INFORMATION

Urinary incontinence is a disorder that generally affects people of allages. The inability to control urination can impact a patient bothphysiologically and psychologically. Urinary incontinence can interferewith a patient's daily activity and impair quality of life. Stressurinary incontinence is one type of urinary incontinence. Actionsincluding straining, coughing, and heavy lifting can cause those withstress urinary incontinence to void urine involuntarily.

Various physiological conditions cause urinary incontinence in women.Stress urinary incontinence generally is caused by two conditions thatoccur independently or in combination, intrinsic sphincter deficiencyand hypermobility. Intrinsic sphincter deficiency (ISD) is a conditionwhere the urethral sphincter fails to coapt properly. When functioningproperly, the urethral sphincter muscles relax to enable the patient tovoid, and the sphincter muscles are otherwise constricted to retainurine. ISD may cause urine to leak out of the urethra during stressfulactions. Hypermobility is a condition where the pelvic floor is weakenedor damaged causing the bladder neck and proximal urethra to rotate anddescend in response to increases in intraabdominal pressure. Whenintraabdominal pressure increases (due, for example, to strain resultingfrom coughing), the hypermobility condition may cause urine leakage.Some women suffer from a combination of ISD and hypermobility.

The methods for treating stress urinary incontinence include placing asling to either compress the urethral sphincter or placing a sling tosupport, elevate or provide a “back stop” to the bladder neck andproximal urethra. Providing support to the bladder neck and proximalurethra maintains the urethra in the normal anatomical position andelevation places the urethra above the normal anatomical position. The“back stop” prevents descent according to the hammock theory such thatthe back stop prevents the bladder neck from descending upon applicationof strain.

Generally, slings are employed to support anatomical structures. Slingsmay be made from one or more materials derived from non-syntheticmaterial(s), for example, mammalian tissue(s), synthetic material(s), orfrom a combination of non-synthetic material(s) and syntheticmaterial(s).

The presence of non-synthetic material(s) can prevent erosion andirritation, caused by the use of synthetic materials alone. It has beenobserved that the interaction between the synthetic material of a slingand the body may cause erosion into the body, e.g., the urethra orvagina. The incorporation of non-synthetic material(s) into the slingprevents this erosion, thereby increasing patient comfort.

After implantation in a patient, slings made from mammalian tissuestypically require a six to twelve month period to be absorbed by thepatient's body, after which the implanted mammalian tissue is notrecognizable from the patient's surrounding tissue. Mammalian tissueslings include tissue harvested from the patient or a donor. In someinstances, the mammalian tissue may be human cadaveric tissue.

SUMMARY OF THE INVENTION

The present invention relates to slings, methods of making such slings,medical kits including such slings, and methods of treating a damagedportion of a patient's body using such slings. Various known surgicalprocedures employ slings to support anatomical structures. Exemplarysurgical applications include the treatment of urinary incontinence, therepair of herniation, and orthopedics generally.

In accordance with one aspect of the invention, cuts are disposedthrough the sling material to provide open areas in the sling, whichenable rapid tissue in-growth into the sling material while maintaininga high tensile strength. The cuts can be slits, holes, and/or apertures.The sling with the cuts according to the invention maintains asubstantially constant width during and after implantation in apatient's body. The risk of pressure necrosis or erosion of the damagedportion of the patient's body caused by uneven sling pressure is reducedbecause the sling width remains substantially constant even when thesling is stretched longitudinally during the implantation procedure.

The benefits of such a sling, which can comprise synthetic material,mammalian tissue, or a combination of synthetic and mammalian tissuematerial with cuts disposed through the material, include rapidfibrosing of the sling, a shortened healing period, and little or nosling movement after implantation. In accordance with the invention,when a sling is employed to treat female urinary incontinence connectivetissue resembling scar tissue will begin to infiltrate one or more openareas disposed in the sling (which is positioned underneath thepatient's urethra). The formation of scar tissue generally adds bulkthat compresses the urethra and provides the support to improve patientcontinence. The scar tissue that infiltrates the sling holds the slingat the site of implantation and inhibits or prevents its movement.

In general, in one aspect, the invention involves a sling for use in amedical application. The sling is made of a sheet of synthetic material,mammalian tissue, or a combination of mammalian tissue and syntheticmaterial. The sheet has a longitudinal axis with a first end portion anda second end portion. The second end portion of the sheet is disposedopposite and away from the first end portion along a longitudinal axis.The sheet also includes a first side and a second side; the second sideis disposed opposite and away from the first side by a distance andalong a perpendicular axis. The perpendicular axis is perpendicular orsubstantially perpendicular to the first axis (i.e., for example alongitudinal axis). The perpendicular axis intersects the longitudinalaxis at the midpoint or substantially the midpoint of the longitudinalaxis. The sheet further includes one or more cuts disposed substantiallyalong at least a portion of the second axis (i.e., for example aperpendicular axis). The cuts are disposed such that upon exposure totensioning force applied to the sheet substantially along thelongitudinal axis during the medical application, the distance along theperpendicular axis remains substantially constant.

Embodiments of this aspect of the invention can include the followingfeatures. The cuts disposed on the sling may be a slit disposed throughthe sheet of material. The slits may be disposed such that at least someof the slits open upon exposure to the tensioning force applied duringthe medical application. The open slits provide open areas on the sling,which permit tissue crosslinking and in-growth therein when implantedinside the body of a patient.

Alternatively, the cuts may comprise any aperture disposed through thesheet of the sling. Upon exposure to the tensioning force applied duringthe medical application, at least some, and generally all, of theapertures on the sling remain open. The apertures that remain openprovide open areas on the sling. The open areas permit tissuecrosslinking and in-growth into the cuts when the sling is implantedinside the body of a patient. The cuts may be disposed substantiallyalong the perpendicular axis of the sling. In some embodiments the cutsmay be equidistant from one another.

In other embodiments, a line may be disposed, as a visual indicator,substantially along at least a portion of the perpendicular axis of thesling. The line can be made by applying a surgical ink to the slingmaterial.

The material of the sling may be derived from mammalian tissuesource(s), synthetic material(s), or a combination of mammaliantissue(s) and synthetic material(s). The mammalian tissue source may behuman, human cadaveric, or tissue-engineered human tissue. The mammaliantissue may alternatively be from an animal source. Suitable sources ofanimal tissues may include porcine, ovine, bovine, and equine tissuesources. The material may be an omnidirectional material, a materialthat has equivalent tensile strength from any direction, such aspericardium or dermis. Alternatively, the material of the sling may bean oriented material, a material that has a single direction where thetensile strength of the material is the highest. Oriented materials mayinclude rectus fascia and/or facia lata.

The synthetic material may be a solid material, a weave, a braid, amesh, or some other suitable construction. The synthetic material sourcemay be nylon, polyethylene, polyester, polypropylene, fluoropolymers,copolymers thereof, and other suitable synthetic materials. The materialmay be a synthetic material that is absorbable by the patient's body.Suitable absorbable synthetic materials may include polyglycolic acid,polylactic acid, and other suitable absorbable synthetic materials. Thesynthetic material may be oriented and have a single direction where thetensile strength of the material is highest. Alternatively, the materialmay be omnidirectional such that any direction of the synthetic materialmay have equivalent tensile strength.

The cuts can be formed through a sheet made of oriented tissue materialalong the grain, i.e., along a single direction where the tensilestrength of the material is the highest. By disposing the cuts along thegrain of the oriented material, the strength of the sheet may besubstantially maintained. Upon exposure to tensioning force applied tothe sheet substantially along the longitudinal axis, the distance alongthe perpendicular axis of the oriented sheet remains substantiallyconstant. Likewise, by forming cuts through and along the highesttensile strength direction of a sheet of synthetic sling material, thestrength of the synthetic sheet may be substantially maintained.

In one embodiment, one or more fasteners are disposed on the sheet ofsling material. The fasteners may be disposed in regions of the sheetwhere there are no cuts. The fasteners may be disposed, for example, ateach of the first end portion and the second end portion of the sheet.Alternatively, or in addition, one or more eyelets may be disposedthrough both the first end portion and the second end portion of thesheet. In one particular embodiment, a fastener, for example a suture,is secured to a sling by threading it through an eyelet disposed throughthe sling.

The sling of the invention may be made of a sheet that is in a shapesuitable for a medical application. Suitable shapes may includerectangular and substantially rectangular. The sling may be octagonal,hexagonal, trapezoidal, elliptical, or some other shape that is suitableto the slings intended placement location within the body. In someembodiments, the sheet has elongated members, which extend substantiallyfrom a central portion of the sheet. The elongated members may beanchored to an anatomical structure in the patient without use of asuture.

In general, in another aspect, the invention relates to a method ofmaking a sling by forming one or more cuts in a sheet of materialprovided in a shape suitable for use in a medical application. The sheetprovided may be derived from mammalian tissue(s), synthetic material(s),or a combination of mammalian tissue(s) and synthetic material(s). Thesheet includes a first end portion and a second end portion. The secondend portion of the sheet is disposed opposite and away from the firstend portion along a longitudinal axis. The sheet also includes a firstside and a second side. The second side is disposed opposite and awayfrom the first side by a distance and along a perpendicular axis. Theperpendicular axis is substantially perpendicular to the longitudinalaxis. The perpendicular axis intersects the longitudinal axis atsubstantially the midpoint of the longitudinal axis. The one or morecuts are formed substantially along at least a portion of theperpendicular axis of the sheet. The cuts are formed in the sheet suchthat the distance along the perpendicular axis of the sheet remainssubstantially constant upon exposure to the tensioning force applied tothe sheet substantially along the longitudinal axis during a medicalapplication.

Embodiments of this other aspect of the invention can include thefollowing features. The method of making the sling can further compriseforming a line substantially along at least a portion of theperpendicular axis of the sling. The line can be formed by applyingsurgical ink to the sling material. The line may be used as a visualindicator during a medical application.

The method of making the sling can further comprise disposing one ormore fasteners at the first end portion of the sheet. One or morefasteners may also be disposed at the second end portion of the sheet.The fasteners may be disposed on regions of the first end portion andthe second end portion of the sheet where cuts are not disposed throughthe material.

The method of making the sling can further comprise sterilizing thematerial and sterilizing the sling according to methods known in the artto make the sling suitable for use in various medical applications. Themethod of making the sling may include packaging the sling in a sterileholder. According to methods of the invention, the sling may be packagedunder conditions that are dry and protective from ultra-violet light.

In general, in a further aspect, the invention involves a method oftreating a damaged portion of a patient's body. A sling is provided andthen used. The sling is made of a sheet of material that has cutsdisposed through the sheet to provide open areas upon implantationinside the patient's body. The material of the sheet may be derived frommammalian tissue(s), synthetic material(s), or a combination ofmammalian tissue(s) and synthetic material(s). The sheet includes afirst end portion and disposed opposite and away from the first endportion along a longitudinal axis is a second end portion. The sheetalso includes a first side and disposed opposite and away from the firstside by a distance and along a perpendicular axis is a second side. Theperpendicular axis is substantially perpendicular to and intersects thelongitudinal axis at substantially the midpoint of the longitudinalaxis. The sheet further includes one or more cuts disposed substantiallyalong at least a portion of the perpendicular axis. The first endportion of the sling sheet is secured to a first anatomical structure inthe body of the patient. Tensioning force is applied substantially alongthe longitudinal axis of the sheet. The second end portion of the slingis secured to a second anatomical structure in the body of the patient.The sling is secured inside the body of the patient such that it'sperpendicular axis lies substantially along a portion of the patient'sbody. The one or more cuts are disposed such that the distance along theperpendicular axis of the sheet remains substantially constant when thesling is secured. The secured sling supports a damaged portion of thepatient's body.

The method of using the sling of the invention may further comprisesecuring the first end portion to an anatomical structure using asurgical fastener. Surgical fasteners employed to secure the sling mayinclude a suture, a clip, a bone anchor, a staple, or other suitablefasteners.

The sling may be secured to an anatomical structure in the body of thepatient. Suitable anatomical structures include: bone, fascia, ligament,or muscle. Alternatively, the sling may be secured in an anchorlessmanner, in which the structure of sling (i.e., tanged portions) providesresistance against movement of the sling in the tissue while tissue ingrowth occurs.

The method of using the sling can further comprise centering the slingat the damaged portion of a patient's body using a line disposedsubstantially along at least a portion of the perpendicular axis as avisual indicator. The line may provide a visual indication of where theone or more cuts are disposed on the sling and the line may be employedto help align the cuts with the damaged portion of the patient's body.

When the cuts are slits, at least some of the slits can be open whensupporting the damaged portion of the patient's body. Alternatively,when the cuts are apertures, at least some of the apertures can remainopen when supporting the damaged portion of the patient's body. The opencuts provide open areas on the sling that permit the patient's tissue tocrosslink and grow into the open areas on the sling once the sling issecured inside the body of the patient. The scar tissue in-growth bothsecures the sling inside the patient's body and provides support to theareas of the body into which the tissues grow.

The method may further comprise evenly distributing pressure on adamaged portion of a patient's body with the secured sling material. Inone embodiment, the sling is employed to treat a female patient withurinary incontinence. The sling material may be implanted to evenlydistribute pressure on a patient's urethra. The sling may be deliveredand implanted to treat female urinary incontinence according totransvaginal, transabdominal, supra-pubic, pre-pubic, or transobturatorapproaches, or some combination of these procedures.

In one embodiment, the sling is employed to treat a patient sufferingfrom ISD. The sling may be implanted such that the one or more cuts onthe sling contact the underside of the patient's sphincter muscle, thefirst side of the sling contacts the under portion of the distal bladderneck and second side of the sling contacts the under portion of theurethra. The sling can be implanted such that the sling material evenlydistributes pressure on a patient's sphincter muscle without applyingpressure to the urethra or bladderneck. Alternatively, the method may beemployed to treat a patient with bladderneck hypermobility and the cutson the sling may be placed adjacent to the patient's mid urethra.

The patient's body can absorb the material of the sling afterimplantation of the sling in the body. The sling material absorbed bythe patient's body may be made from mammalian tissue. Alternatively,synthetic absorbable sling material may be absorbed by the patient'sbody after implantation therein.

In another aspect, the invention relates to a sling for use in a medicalapplication including a sheet including a synthetic material. The sheetincludes a first end portion and a second end portion, the second endportion disposed opposite and away from the first end portion along afirst axis and a first side and a second side, the second side disposedopposite and away from the first side by a distance and along a secondaxis that is substantially perpendicular to the first axis and thatintersects the first axis at substantially the midpoint of the firstaxis. The sheet further includes a non-synthetic material wrapped aroundat least a portion of the sheet.

In yet another aspect, the invention relates to a sling for use in amedical application including a sheet including a synthetic material.The sheet includes a first end portion and a second end portion, thesecond end portion disposed opposite and away from the first end portionalong a first axis and a first side and a second side, the second sidedisposed opposite and away from the first side by a distance and along asecond axis that is substantially perpendicular to the first axis andthat intersects the first axis at substantially the midpoint of thefirst axis. The sheet further includes a non-synthetic material attachedto the sheet by at least one of glue, a suture, a staple, a rivet, aneyelet rivet, a fastener, a clip, and combinations thereof.

In still another aspect, the invention relates to a sling for use in amedical application including a sheet including a synthetic material.The sheet includes a first end portion and a second end portion, thesecond end portion disposed opposite and away from the first end portionalong a first axis and a first side and a second side, the second sidedisposed opposite and away from the first side by a distance and along asecond axis that is substantially perpendicular to the first axis andthat intersects the first axis at substantially the midpoint of thefirst axis. The sheet further includes a non-synthetic material disposedadjacent to the sheet, wherein the non-synthetic material defines atleast one or more slits disposed substantially along at least a portionof the second axis.

In various embodiments of the foregoing aspect, at least some of theslits open upon exposure to a tensioning force applied during themedical application. Furthermore, each of the slits may include anaperture. The apertures may remain open after exposure to the tensioningforce applied during the medical application. In another embodiment, theslits are disposed from the first side to the second side of the sheetsubstantially along the second axis. The slits may be disposedequidistant from one another substantially along the second axis.

In one embodiment of the foregoing aspects of the invention, thenon-synthetic material wraps around at least a portion of the sheet. Thenon-synthetic material can be wrapped completely about at least aportion of the sheet. The non-synthetic material may be free floatingabout the sheet. In another embodiment, the non-synthetic material isdisposed adjacent to at least a portion of one of a top surface and abottom surface of the sheet. In yet another embodiment, thenon-synthetic material is disposed adjacent to at least a portion ofboth the top surface and the bottom surface of the sheet. In yet anotherembodiment, the non-synthetic material may be attached to the sheet byat least one of glue, a suture, a staple, a rivet, an eyelet rivet, afastener, a clip, and combinations thereof.

In various embodiments of the foregoing aspects of the invention, thesling further includes a second non-synthetic material disposed adjacentto the sheet and opposite the first non-synthetic material. In anotherembodiment, the non-synthetic material permits tissue in-growth thereinwhen the sling is implanted in a body of a patient. The syntheticmaterial may include a material selected from the group consisting ofnylon, polyethylene, polyester, polypropylene, fluoropolymers, andcombinations thereof.

In one embodiment, the non-synthetic material is disposed adjacent to aurethra when placed within a body of a patient. Additionally, thenon-synthetic material can extend to each side of an endopelvic fasciawhen placed within a body of a patient. In various embodiments, thenon-synthetic material is about 4 cm to about 10 cm in length along thefirst axis of the sheet. Alternatively, the non-synthetic material isabout 5 cm to about 9 cm in length along the first axis of the sheet.Alternatively, the non-synthetic material is about 7 cm in length alongthe first axis of the sheet.

In various embodiments, the non-synthetic material is selected from thegroup consisting of bovine, porcine, ovine, equine, human cadaveric, andtissue-engineered tissues. In one embodiment, the non-synthetic materialincludes an acellular matrix processed from human skin. Thenon-synthetic material may be capable of remodeling into a healthy layerof tissue.

In other embodiments of the foregoing aspects, at least a portion of atleast one of the first side and the second side may be tanged.Furthermore, at least a portion of at least one of the first side andthe second side may be non-tanged. In various embodiments, the sheetincludes a propylene mesh. Furthermore, the sheet may include fibersselected from the group consisting of colored, radiopaque, andcombinations thereof. Moreover, the sheet may be of a type selected fromthe group consisting of woven, knitted, felted, non-woven andcombinations thereof. In addition, the sheet may have a substantiallyrectangular shape. In another embodiment the sheet includes a coating.The coating may include a pharmaceutical for delivery to a patient whenthe sling is implanted in a body of the patient.

In another embodiment, the sling further includes a second sheetincluding a synthetic material including a first end portion and asecond end portion, the second end portion disposed opposite and awayfrom the first end portion along a first axis of the second sheet and afirst side and a second side, the second side disposed opposite and awayfrom the first side by a distance and along a second axis of the secondsheet that is substantially perpendicular to the first axis and thatintersects the first axis of the second sheet at substantially themidpoint of the first axis of the second sheet. The non-syntheticmaterial may be positioned between the first end of the first sheet andthe second end of the second sheet. Furthermore, the non-syntheticmaterial may be attached to the first sheet and the second sheet by atleast one of glue, a suture, a staple, a rivet, an eyelet rivet, afastener, a clip, and combinations thereof.

In another aspect, the invention relates to a method of making a sling,including providing a sheet suitable for a medical application, thesheet including a synthetic material and including a first end portionand a second end portion, the second end portion disposed opposite andaway from the first end portion along a first axis, the sheet alsoincluding a first side and a second side, the second side disposedopposite and away from the first side by a distance and along a secondaxis that is substantially perpendicular to the first axis, and thatintersects the first axis at substantially the midpoint of the firstaxis. The method further includes positioning a non-synthetic materialadjacent to at least a portion of the sheet, wherein the non-syntheticmaterial is wrapped around at least a portion of the sheet.

In another aspect, the invention relates to a method of making a sling,including providing a sheet suitable for a medical application, thesheet including a synthetic material and including a first end portionand a second end portion, the second end portion disposed opposite andaway from the first end portion along a first axis, the sheet alsoincluding a first side and a second side, the second side disposedopposite and away from the first side by a distance and along a secondaxis that is substantially perpendicular to the first axis, and thatintersects the first axis at substantially the midpoint of the firstaxis. The method further includes attaching a non-synthetic material tothe sheet by at least one of glue, a suture, a staple, a rivet, aneyelet rivet, a fastener, a clip, and combinations thereof.

In yet another aspect, the invention relates to a method of making asling, including providing a sheet suitable for a medical application,the sheet including a synthetic material and including a first endportion and a second end portion, the second end portion disposedopposite and away from the first end portion along a first axis, thesheet also including a first side and a second side, the second sidedisposed opposite and away from the first side by a distance and along asecond axis that is substantially perpendicular to the first axis, andthat intersects the first axis at substantially the midpoint of thefirst axis. The method further includes positioning a non-syntheticmaterial adjacent to the sheet and disposing at least one or more slitsin the non-synthetic material substantially along at least a portion ofthe second axis.

In any of the embodiments of the aspects of the invention above, thesling may be encased wholly or partly within a protective sleeve. Thesling may be free-floating within the sleeve or fastened to the sleeveat one or more points. The sleeve may aid in easing implantation of thesling and may protect the sling during implantation. The sleeve may beremoved according to various methods once the sling has been implanted.

These and other objects, along with advantages and features of thepresent invention, will become apparent through reference to thefollowing description, the accompanying drawings, and the claims.Furthermore, it is to be understood that the features of the variousembodiments described herein are not mutually exclusive and can exist invarious combinations and permutations.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, like reference characters generally refer to the sameparts throughout the different views. Also, the drawings are notnecessarily to scale, emphasis generally being placed upon illustratingthe principles of the invention. In the following description, variousembodiments of the present invention are described with reference to thefollowing drawings, in which:

FIG. 1 illustrates a plan view of one embodiment of a sling according tothe invention;

FIG. 2 illustrates a plan view of another embodiment of a substantiallyrectangular shaped embodiment of a sling in accordance with theinvention;

FIG. 3 illustrates a plan view of another embodiment of a substantiallyrectangular shaped sling in accordance with the invention;

FIG. 4 illustrates a plan view of another embodiment of a rectangularshaped sling in accordance with the invention;

FIG. 5 illustrates a plan view of another embodiment of a rectangularshaped sling in accordance with the invention;

FIG. 6A illustrates a plan view of another embodiment of a slingincluding two pairs of elongated members extending from a centralportion of the sling in accordance with the invention;

FIG. 6B illustrates a plan view of another embodiment of a slingincluding two pairs of elongated members extending from a centralportion of the sling in accordance with the invention;

FIG. 7A illustrates a plan view of another embodiment of a slingincluding elongated end members extending from a central portion of thesling in accordance with the invention;

FIG. 7B illustrates a plan view of another embodiment of a slingincluding elongated end members extending from a central portion of thesling in accordance with the invention;

FIG. 8A is a cross section of the female pelvis illustrating thelocation of a sling similar to the sling of FIG. 4 relative to theurethra and the vagina and anchored to the pubic bone;

FIG. 8B is a cross section of the female pelvis illustrating thelocation of a sling similar to the sling of FIG. 4 relative to theurethra and the vagina and anchored to fascial urethra supports.

FIG. 9A is a sagittal section of a female pelvis illustrating thelocation of a sling similar to the sling of FIG. 4 relative to themid-urethra and distal urethra and anchored to the inferior edge at theposterior aspect of the pubic bone;

FIG. 9B is a sagittal section of a female pelvis illustrating thelocation of a sling similar to the sling of FIG. 4 relative to themid-urethra and distal urethra and anchored to the pubic bone betweenthe superior and the inferior edge on the posterior side of the pubicbone;

FIG. 9C is a sagittal section of a female pelvis illustrating thelocation of a sling similar to the sling of FIG. 4 relative to themid-urethra and distal urethra and anchored to the pubic bone at thesuperior end of the pubic bone;

FIG. 10 is a sagittal section of a female pelvis illustrating thelocation of the sling similar to the sling of FIG. 3 relative to thebladdemeck, sphincter (not shown), and the urethra and anchored to thepubic bone;

FIG. 11A illustrates a partial perspective view of a sling in accordancewith the invention, where the non-synthetic material wraps around aportion of the synthetic mesh material;

FIG. 11B illustrates a side view of the sling of FIG. 11A;

FIG. 12A illustrates a partial perspective view of an alternativeembodiment of a sling in accordance with the invention, where thenon-synthetic material is attached to the surface of only one side of aportion of the synthetic mesh material;

FIG. 12B illustrates a side view of the sling of FIG. 12A;

FIG. 13A illustrates a partial perspective view of an alternativeembodiment of a sling in accordance with the invention, where thenon-synthetic material is attached to the surface of both sides of aportion of the synthetic mesh material;

FIG. 13B illustrates a side view of the sling of FIG. 13A;

FIG. 14 illustrates a partial perspective view of an alternativeembodiment of a sling in accordance with the invention, where both endsof the non-synthetic material are glued to an end of each of twoseparate pieces of synthetic mesh material;

FIG. 15 illustrates a partial perspective view of an alternativeembodiment of a sling in accordance with the invention, where both endsof the non-synthetic material are sutured to an end of each of twoseparate pieces of synthetic mesh material;

FIG. 16 illustrates a partial perspective view of an alternativeembodiment of a sling in accordance with the invention, where both endsof the non-synthetic material are stapled to an end of each of twoseparate pieces of synthetic mesh material;

FIG. 17 illustrates a partial perspective view of an alternativeembodiment of a sling in accordance with the invention, where both endsof the non-synthetic material are attached via an eyelet rivet to an endof each of two separate pieces of synthetic mesh material;

FIG. 18 illustrates a partial perspective view of an alternativeembodiment of a sling in accordance with the invention, where both endsof the non-synthetic material are attached via clips to an end of eachof two separate pieces of synthetic mesh;

FIG. 19A illustrates a partial perspective view of an alternativeembodiment of a sling in accordance with the invention, where thenon-synthetic material wraps completely around a portion of the mesh;

FIG. 19B illustrates a side view of the sling of FIG. 19A; and

FIG. 20 illustrates a plan view of an alternative embodiment of a slingin accordance with the invention, where the non-synthetic materialincludes slits.

DESCRIPTION

Referring to FIG. 1, in one embodiment according to the invention, asling 2 is a substantially rectangular sheet 6 made of one or morematerials. Sheet 6 includes a first end portion 14 at one end of thesheet 6 and a second end portion 24 at the opposite end of the sheet 6along a first longitudinal axis 34. The sheet 6 also includes a firstside 18 and a second side 28. The second side 28 is disposed oppositethe first side 18 along a second axis 38 that is substantiallyperpendicular to the first longitudinal axis 34. The perpendicular axis38 substantially bisects the longitudinal axis 34. The perpendicularaxis 38 extends the distance 150 from the first side 18 to the secondside 28.

Generally, the sizes and shapes of the mesh and the non-syntheticmaterial comprising the sling will vary to suit a particular embodiment.The sling 2 can be rectangular or substantially rectangular in shape orthe sling 2 can be an octagonal shape. In alternative embodiments, thesling 2 has other shapes suitable to its intended placement locationwithin the body such as trapezoidal, hexagonal, or elliptical shapes.Exemplary shapes are described in U.S. Pat. No. 6,042,534, thedisclosure of which is hereby incorporated by reference.

The sheet 6 includes one or more cuts 10 disposed along at least aportion of the length of the perpendicular axis 38. The cuts 10 aredisposed such that the length of the perpendicular axis 38 remainssubstantially constant following the application of tension appliedsubstantially along the longitudinal axis 34 of the sheet 6. Suchtension may be applied, for example, during implantation of the sling 2in a patient. The cuts 10 can be, for example, slits or alternativelyapertures disposed through the full thickness of sheet 6. In someembodiments, the cuts 10 may not extend through the entire thickness ofthe sheet 6. In a particular embodiment, cuts 10 through the sheet 6parallel the direction of high tensile strength of the synthetic slingmaterial may substantially maintain the strength of the syntheticmaterial.

In one embodiment, the longitudinal axis 34 of the sheet 6 ranges fromabout 2.5 cm to about 45 cm in length, and the perpendicular axis 38ranges from about 1.0 cm to about 3.0 cm. The sheet is preferably 20 to30 cm in length and 1 to 3 cm wide, though larger and smaller slings arecontemplated depending upon the size of the patient and the surface areaof the body part that requires support. The cuts 10 are disposedsubstantially parallel to the longitudinal axis 34 and the cuts 10 rangefrom about 0.5 cm to about 28 cm in length. In some embodiments, thecuts 10 range from about 0.5 cm to about 1.5 cm in length. The thicknessof the sheet 6 (not depicted in the plan view of FIGS. 1, 2, 3, 4, 5,6A, 6B, 7A, and 7B) can be uniform over the entire piece of the sheet 6or it can vary at one or more different locations of the sheet 6. Thethickness of a material from a mammalian source can range from about0.01 inches to about 0.2 inches, but typically will be about 0.05inches. The thickness of a material from a synthetic source may rangefrom about 0.01 inches to about 0.05 inches, but typically will be about0.035 and a uniform thickness. The material construction may impact thematerial thickness such that, for example, a weave may have thickerregions where the fibers intersect and the material thickness may not beuniform.

In one embodiment, according to the invention, the sheet 6 may be madeof non-synthetic material(s), e.g., mammalian tissue(s), syntheticmaterial(s), or a combination of non-synthetic material(s), andsynthetic material(s). One or more mammalian tissues including porcine,ovine, bovine, equine, human cadaveric, or tissue-engineered tissue(s)may be employed to make the sheet 6. The sheet 6 may be derived fromomnidirectional tissue(s), tissues where the material has equivalenttensile strength from any direction. Exemplary omnidirectional materialsinclude dermis and/or pericardium. Suitable materials for use inaccordance with this invention include a chemically processed acellularhuman dermis product that preserves, undamaged, the bioactive structuraldermal matrix and which is freeze-dried for storage, such as AlloDerm®acellular tissue available form Lifecell (Branchburg, N.J.).

In one embodiment, the non-synthetic material is REPLIFORM® TissueRegeneration Matrix, commercially available from Boston ScientificCorporation (Natick, Mass.). The matrix is human dermal allograft that,when placed within the body, serves as a template to facilitatefibroblast mediated regeneration of normal soft tissue. The matrix isformed of banded collagen fibers, elastin, proteoglycans, and vascularplexus. The REPLIFORM® Tissue Regeneration Matrix may be from about 3 cmto about 20 cm in length. In one embodiment, the REPLIFORM® TissueRegeneration Matrix may be from about 5 cm to about 10 cm in length. Ina particular embodiment, the REPLIFORM® Tissue Regeneration Matrix maybe about 7 cm in length.

In another embodiment, oriented mammal tissue(s), i.e., tissues having asingle direction where the tensile strength of the tissue material ishighest, including rectus fascia and/or facia lata may be used for thesheet 6. Suitable cleaned and sterilized oriented human tissue materialsmay be obtained from tissue banks.

In one embodiment according to the invention, animal tissues may beselected from tissues available from government regulated slaughterhouses. Animal tissues may be dehydrated with a dehydrating fluid, suchas ethyl alcohol or the like, prior to treatment with chemicalcrosslinking agents, to allow for improved penetration. Thecross-linking agent cross-links collagen in the tissues to make thetissue stronger and reduce the antigenicity of the tissue. Other agentssuch as pepsin may also be used to further reduce antigenicity. In oneembodiment according to the invention, the tissues may be cross-linkedby using one or more of the following treatment agents: glutaraldehyde,dialdehyde, glutaraldehyde starch, dialdehyde starch, an epoxy compoundor ionizing radiation. Certain processes (such as heat, radiation or pHchange) or agents such as halogens, enzymes, organic solvents,detergents, sodium hydroxide, hydrochloric acid, sodium hypochlorite orhydrogen peroxide) may be used to inactivate viruses with and withoutprotein coats during the manufacturing process. The tissue may also betreated with a highly volatile chemical such as, for example, propyleneoxide, to assist with the sterilization of the tissue. Sterilization maybe accomplished using one or more of the following treatments:glutaraldehyde, alcohol, propylene oxide or irradiation sterilization.The treatment of the tissue, with a combination of these materials andprocesses, can both cross-link the tissue and render the tissue sterilefor implantation inside the body of a patient. Other processingtechniques may be suitable, as known in the art, including mechanicaland chemical processing steps to affect various characteristics of thetissue (i.e., acellularity, antigenicity, resorbability).

In another embodiment according to the invention, the synthetic slingmaterial may be a solid material, a weave, a braid, a mesh or analternate material construction. The synthetic material may be apolymer. Suitable polymer sources for the sling 2 may include nylon,polyethylene, polyester, polypropylene, fluoropolymers or copolymersthereof. An exemplary synthetic polyester material suitable for use inthe sling 2 according to the invention is available under the tradedesignation Dacron®, from E. I. du Pont de Nemours and Company(Wilmington, Del.). In another embodiment, suitable synthetic materialsinclude the fluoropolymers polytetrafluoroethylene (PTFE), which hasnon-melt processible characteristics, and fluorinated ethylene propylene(FEP), which has melt-processible characteristics, both fluoropolymersare available under the trade designation Teflon®, from E. I. du Pont deNemours and Company (Wilmington, Del.). A suitable PTFE material ofsolid material construction is available under the trade designationGORE-TEX®, from W. L. Gore & Associates, Inc. (Flagstaff, Ariz.).

In a particular embodiment, the synthetic sling material comprises mesh.The mesh may have any of a number of knits, weaves, braids ornon-wovens, such as those described in U.S. Pat. Nos. 5,569,273;5,292,328; 5,002,551; 4,838,884; 4,655,221; 4,652,264; 4,633,873;4,520,821; 4,452,245; 4,347,847; 4,193,137; 5,124,136; 3,054,406; and2,671,444 the disclosures of which are hereby incorporated by reference.

The mesh material may be fabricated from any of a number ofbiocompatible materials such as nylon, polyethylene, polyester,polypropylene, fluoropolymers, copolymers thereof, combinations thereof,or other suitable synthetic material(s). The material may be, forexample, a synthetic material that is absorbable by the patient's body.Suitable absorbable synthetic materials include polyglycolic acid,polylactic acid, and other suitable absorbable synthetic materials. Themesh material may be fabricated from one or more yams, which yams may bemade from one or more materials. The mesh may be produced according tonumerous fabrication processes, and may be designed to permit rapidtissue revascularization and tissue in-growth by having largeinterstitial spaces. For example, each yarn of the mesh may have voidareas between yarn filaments and the fabrication process may createcrevices. An exemplary weave is a tricot knit with two yams per needle.In a preferred embodiment, the mesh is composed of polypropylenemonofilament yarns.

In yet another embodiment, absorbable synthetic materials may besuitable for a sling 2 in accordance with the invention. For example,polyglycolic acid (PGA), polylactic acid (PLA), and other availableabsorbable synthetic materials may be suitable. A PGA material that maybe suitable for use in sling 2 is available under the trade designationDexon®, from American Cyanamid Company (Wayne, N.J.). Other suitablepolymeric and non-polymeric synthetic materials may be employed inaccordance with the invention.

In another embodiment, combinations of synthetic materials and mammaliantissues may also be used according to the invention. These combinationsmay include material having a combination of parts, including, forexample, parts made of synthetic polymers and parts made of processedanimal tissues. Such combinations also include materials that have bothsynthetic polymers and animal cells that are treated so as to cross-linkthe collagen or other commonly antigenic fibers in the animal cells.

Tangs (i.e., sharp projections or frayed edges) often form along anyedge of the material forming the sling when the material is cut,chopped, torn, frayed or otherwise manufactured. It has been observedthat some tangs may be advantageous in some respects, such as serving toanchor the sling in the tissue (particularly in an application where noindependent anchoring structure is utilized). However, in otherrespects, some tangs may erode the adjacent tissue when the sling isinserted into a patient's body. Accordingly, erosion effects may bereduced by smoothing, rounding, or removing some or all of the tangsalong the length of the sling. Any process that will smooth, round orremove the tangs to remove their sharp edges is suitable. For example,the tangs may be heat smoothed by burning or melting. Such a heatprocess causes melting of the sharp tangs back to the woven knot forminga non-tanged section. The non-tanged section may be located on bothsides and occupying, for example, about 1 to 4 cm on either side of theperpendicular axis. The tangs may be removed, for example, along a 5, 6,7, 8, 9 or 10 cm portion of the side of the mesh material.

An exemplary method of making a sling of the invention from a materialincludes manufacturing a sling material and form a non-tanged section ona portion of a material at the sides and adjacent the perpendicularaxis. The sling may be formed from the cutting to size of a larger pieceof sling material. The tangs on a portion of each side are unformed,smoothed, rounded or removed (e.g., to the woven knots) to form anon-tanged section. The non-tanged section may span a segment of thesides and have a length up to about 4 cm, but usually at least about 1cm. The segment is preferably centered on the perpendicular axis. In analternative embodiment, the non-tanged section may span a segment ofsides having a length of 5, 6, 7, 8, 9 or 10 cm. In one version of themethod, the tangs are smoothed, rounded or removed by exposing the tangsto a source of heat (i.e., by contact or by bringing the heat sourceinto close proximity to the tangs). In an alternative method, a straightblade edge that is heated to a sufficient temperature to simultaneouslycut and smooth the tangs may be employed.

According to one embodiment of the invention, following implantation ofa sling 2 in the body of the patient, at least some, and generally allor most, of the cuts 10 provide open areas through the sling 2. Tissuewill begin to grow into these open areas. The tissue in-growth securesthe sling 2 position inside the patient's body.

In one particular embodiment illustrated in FIG. 1, the first 1 cm andthe last 1 cm of the longitudinal axis 34 do not have any cuts 10. Afastener 46 for securing the sling 2 to an anatomical structure of thepatient can be disposed in the 1 cm region at each end of thelongitudinal axis 34. Alternatively, as shown in FIG. 2, one or moreattachment sites 48, for example, eyelets, may be disposed throughoutthe sling 2 and located at, for example, the first end portion 14 andthe second end portion 24 of the sling. In one particular embodimentillustrated in FIG. 5, the fasteners 46 are, for example, sutures thatare disposed on the sling 2 by threading them through the eyelets 48 inthe synthetic sheet 6 sling 2. In one embodiment, the fastener 46 is,for example, a suture, clip, staple, anchor. In alternative embodiments,the fastener 46 is pre-attached to the sling 2.

In some embodiments, the cuts 10 are disposed such that the distancebetween adjacent cuts 160 is equal. The distance between equallydistanced adjacent cuts 160 may range from about 5 mm to about 1.25 cmin length, for example. The cuts 10 disposed adjacent and equidistantmay be disposed along the perpendicular axis 38 from the first side 18to the second side 28 of the sling 2. In one embodiment, the cuts 10 aredisposed about the region of the sling 2 where the perpendicular axis 38and the longitudinal axis 34 intersect. A single cut 10 may be employedand it can be disposed at any point along the perpendicular axis 38. Thecuts 10 are disposed such that the distance 150 remains substantiallyconstant upon exposure to a tensioning force applied substantially alongthe longitudinal axis 34 during a medical application (such as aprocedure to implant the sling 2 in the body of a patient to treat ISD).

In one embodiment, a sling made of a synthetic material is disposed withcuts 10 that are slits 10A. The unimplanted sling 2 distance 150 is 2.0cm. After exposure to tensioning force, the implanted sling 2 has adistance 150 that ranges between about 1.6 cm and about 2.0 cm. In anembodiment, as shown in FIG. 2, where the cuts 10 are slits 10A that aredisposed along the high tensile strength direction of the syntheticmaterial, the sling 2 distance 150 is maintained closer to the originaldistance 150, at about 2.0 cm.

In one embodiment, the sheet 6 is derived from the oriented humancadaveric tissue fascia lata, and the cuts 10 are disposed through andalong the grain of the sheet 6 made of oriented material. The cuts 10are disposed on the sheet 6 so that the width of the sheet 6 (at leastalong the perpendicular axis 38) is maintained at substantially the samedistance 150 before, during, and after the application of tensioningforce substantially along the longitudinal axis 34 such as would beapplied to the sheet 6 during a medical application. Such tensioningforce is applied to the sling 2 when, for example, the sling 2 isimplanted inside a female patient in a medical procedure designed totreat stress urinary incontinence.

Generally, material derived from mammalian tissue does not have any cutsor open areas. The time period for slings made from mammalian tissuematerial lacking any cuts or open areas to absorb into the patient hostis generally six to twelve months. Likewise, solid, tightly woven, orclosely knit absorbable synthetic materials generally do not have openareas. The time period typically required for such synthetic absorbablematerials to be absorbed by the patient's body is between about one toabout six months. Disposing the cuts 10 through the sheet 6 allows rapidtissue in-growth, which anchors the sling 2 at the location where it wasimplanted and generally lessens the time it takes for the sheet 6 toabsorb into the patient's body and thus lessens the healing process.

On a sling 2 made of mammalian tissue or absorbable synthetic material,the cuts 10 open areas will be absorbed into the area adjacent to thepatient's body within a few weeks after implantation. The time periodrequired for the entire sling 2 made from mammalian tissue or absorbablesynthetic material to be absorbed by the patient's body may be reducedin proportion to the open surface area on the sling 2. Thus, where cuts10 are disposed so that sling 2 made of mammalian tissue has fiftypercent open surface area, the time period for the sling 2 to beabsorbed into the patient's body may be reduced to between about threeand twelve months as compared to the minimum six months for mammaliantissue material lacking any cuts.

As shown in FIG. 2, a substantially rectangular sling 2 according to oneembodiment of the present invention has cuts 10 that are slits 10Aextending through the thickness of the sheet 6. The slits 10A aredisposed such that they are alternately offset to the left and to theright of the perpendicular axis 38. As shown, a longer portion of slits10A extends from the perpendicular axis 38 to the first end portion 14,and this alternates in that the next slit 10A has its longer portionlocated from the perpendicular axis 38 to the second end portion 24 andso on. Thus FIG. 2 shows an alternating pattern of offset slits 10A. Inother embodiments, other patterns are used. In all variations, the cuts10 are disposed substantially along at least a portion of theperpendicular axis 38.

In one embodiment, the slits 10A are disposed through the sheet 6, andthey open upon exposure to a substantially longitudinal tensioning forcethat is applied to the sling 2 during a medical application. Oneexemplary medical application is the implantation of the sling 2 intothe body of a female patient to treat stress urinary incontinence. Theopened slits 10A provide open areas that allow rapid scar tissueformation and tissue in-growth generally. These opened slits 10A permittissue crosslinking and tissue in-growth into the sling 2 once the sling2 is secured inside the body of the patient.

The slits 10A are disposed on the sling 2 such that when the sling 2 isimplanted inside the patient's body, the slits 10A provide openings thatallow tissue in-growth at the site of the damaged portion of thepatient's body that the sling 2 is employed to support. In oneembodiment, the sling 2 is employed to support a patient's urethra. Theslits 10A are disposed on the sling 2 along the perpendicular axis 38such that when implanted adjacent to the patient's urethra, the openareas allow in-growth to the regions of the urethra that requiresupport. In some embodiments, one or more of the slits 10A are openedwhen the sling 2 is positioned at an angle surrounding the patient'surethra.

In the embodiment of FIG. 3, a substantially rectangular shaped sling 2of the present invention has cuts 10 that are apertures 10B. Theapertures 10B are disposed about the perpendicular axis 38 such thatthey are alternately offset to the left and to the right of theperpendicular axis 38. The apertures 10B are disposed about theperpendicular axis 38 as the alternately offset slits 10A were disposedin FIG. 2.

The apertures 10B provide open areas in sling 2 once disposed throughthe sheet 6. At least some, and usually all, of the apertures 10B remainopen upon exposure to tensioning force applied along the longitudinalaxis 34 of the sling 2 during the medical application. When, forexample, the sling 2 is implanted inside the patient, the apertures 10Bopen areas generally permit scar tissue to grow into the sling 2. Thesize, shape, and placement of each of the apertures 10B may be selectedto provide a desired surface area when implanted. In one embodiment, thesize of the apertures 10B and the aperture 10B location on the sling 2are selected such that when implanted inside the patient, scar tissuewill grow through the apertures 10B to support an adjacent damagedportion of a patient's body. The apertures 10B are shown as diamondshapes in FIG. 3, but other shapes are possible.

According to the invention, the choice of the size, shape, quantity, andlocation of the cuts 10 and the choice of sheet 6 may be made tomaximize open surface area while maintaining the distance 150substantially constant upon exposure to a surgical tensioning force.

The percentage by which the distance 150 reduces will depend on thenumber of cuts 10 and the material type 6, whether from mammaliantissue, synthetic material, or a combination of mammalian tissue andsynthetic material. The placement of the cuts 10 on the material willalso impact the percentage by which the distance 150 may reduce. When,for example, the cuts 10 are formed along the grain of an orientedmammalian tissue, the distance 150 of the sling 2 may be reduced by alower percentage then if an omnidirectional tissue material wereemployed.

In one embodiment where the sheet 6 is derived from an oriented tissueand the cuts 10 are disposed along the grain of the sheet 6, whenexposed to surgical tensioning force the sling 2 will maintain asubstantially constant distance 150. Generally, an oriented materialsling 2 will support more cuts 10 while maintaining a substantiallyconstant distance 150 when exposed to the same surgical tensioning forcethan an otherwise identical sling 2 made of a sheet 6 derived from anomnidirectional tissue material.

Cuts 10 that are apertures 10B generally have a larger open surface areathan cuts 10 that are slits 10A, which results in a greater reduction inthe perpendicular distance 150 due to more of the sheet 6 stretching inthe longitudinal direction upon exposure to tensioning force. Generally,the distance 150 of slings 2 disposed with cuts 10 that are slits 10Awill reduce by between about zero and about twenty percent upon exposureto surgical tensioning force and/or when implanted. The implanteddistance 150 of slings 2 disposed with cuts 10 that are apertures 10Bwill generally reduce by between about zero and about fifty percent uponexposure to surgical tensioning force and/or when implanted.

FIG. 4 provides an alternative embodiment where the line 42 is a visualindicator disposed along the perpendicular axis 38 of the rectangularsling 2. The line 42 is a visual guide employed to align slits 10Adisposed on the sling 2 with the damaged portion of the patient's body.In one disclosed embodiment, the slits 10A are equal in length, disposedalong the perpendicular axis 3 8 and the substantial midpoint of eachslit 10A intersects with line 42. The line 42 may be used to evenlyalign the slits 10A with the portion of the patient's body that thesling 2 is employed to support.

In one particular embodiment, the sling 2 is employed to treat femalestress urinary incontinence and is used to support the patient'surethra. During implantation, the surgeon applies tension to the sling 2and visually aligns line 42 such that it is adjacent to the portion ofthe patient's urethra requiring support. The slits 2 are selectivelydisposed about line 42 to target these portions of the patient'surethra. Some or all of the slits 10A disposed on line 42 of theimplanted sling 2 provide open areas to the patient's urethra. Some orall of the slits 10A may open when the sling 2 is bent around tosurround the patient's urethra. Other slits 10A may open upon exposureto substantially longitudinal tensioning force during the medicalapplication. Very soon after being placed inside the patient's body,scar tissue will begin to grow into the slings 2 open areas to supportthe targeted portion of the patient's urethra.

In the embodiment of FIG. 5, the sling 2 has a single cut 10, slit 10A,disposed along the perpendicular axis 38. A surgical fastener 46 isdisposed at both the first end portion 14 and the second end portion 24of the sling 2. The fastener 46, disposed at the first end portion 14,is used to anchor sling 2 to a first anatomical structure in the body ofa patient. The fastener 46, disposed at the second end portion 24, isused to anchor sling 2 to a second anatomical structure in the body of apatient.

In one embodiment, the fastener 46 is a suture. In alternativeembodiments, the fastener 46 is pre-attached to the sling 2 and mayinclude a clip, a bone anchor, a staple, and/or other suitablefasteners. In a further alternative embodiment, the sling may be securedin an anchorless manner, in which the structure of sling (i.e., tangedportions) provides resistance against movement of the sling in thetissue while tissue in growth occurs.

In a particular embodiment, the sling of FIG. 5 is used to treat apatient suffering from ISD. The surgeon anchors the first end portion 14to a first anatomical structure, aligns the single cut 10, slit 10A,with the patient's sphincter muscle, and then anchors the second endportion 24 to a second anatomical structure. The cut 10A provides opensurface area upon implantation in the patient's body. Soon afterimplantation, scar tissue begins to grow generally into the open surfacearea adjacent to the sphincter muscle to compress the sphincter muscleand improve continence. This scar tissue formation quickly maintains thesling 2 in the place where the surgeon positioned it.

The slings 2 of FIGS. 6A and 6B feature two first end portion elongatedmembers 114 a and 114 b and two second end portion elongated members 124a and 124 b extending from the central portion of sling 2. The slits 10Aare disposed about the perpendicular axis 38. FIG. 6A has slits 10A thatare disposed along the perpendicular axis 38. FIG. 6B has slits 10A thatare disposed so that they are alternately offset to the left and to theright of the perpendicular axis 38.

The slings 2 of FIGS. 7A and 7B feature a first end portion elongatedmember 114 and a second end portion elongated member 124 extending fromthe central portion of sling 2. Cuts 10 are disposed about theperpendicular axis 3 8 of sling 2. FIG. 7A has slits 10A that arealternately offset to the left and the right along the perpendicularaxis 38. FIG. 7B has a cut 10 that is an aperture 10B disposed at themidpoint of the longitudinal axis 34 and the perpendicular axis 38.

A method of making a sling 2 of the invention (depicted in, for example,FIG. 4) from a sheet 6 includes, in overview, the steps of: providing asheet 6 in a shape suitable for a medical application and forming one ormore cuts 10 substantially along the perpendicular axis 38 of the sheet6. The sheet 6 includes a first end portion 14 and a second end portion24, the second end portion 24 is disposed opposite and away from thefirst end portion 14 along a longitudinal axis 34. The sheet 6 alsoincludes a first side 18 and a second side 28, the second side 28 isdisposed opposite and away from the first side 18 by a distance 150 andalong a perpendicular axis 38. The perpendicular axis 38 issubstantially perpendicular to the longitudinal axis 34, and theperpendicular axis 38 intersects the longitudinal axis 34 atsubstantially the midpoint of the longitudinal axis 34. Forming one ormore cuts 10 disposed substantially along at least a portion of theperpendicular axis 38. The cuts 10 are formed such that the distance 150remains substantially constant upon exposure to tensioning force appliedto the sheet 6 substantially along the longitudinal axis 34 during themedical application.

A first step in making the sling 2 is obtaining sheet 6 in a shapesuitable for use in a medical application. Exemplary materials may beobtained from mammalian tissues, synthetic material or a combination ofmammalian tissue and synthetic material. Mammalian tissue sourcesinclude human cadaveric, tissue-engineered products, porcine, ovine,bovine, equine and/or other tissues. The mammalian material may beomnidirectional, oriented, or a combination of the two.

Omnidirectional tissues include dermis and pericardium. One chemicallyprocessed acellular human dermis product that preserves, undamaged, thebioactive structural dermal matrix and which is freeze-dried for storageis suitable for use as the sheet 6 in accordance with this invention.The removal of cells from the otherwise intact dermal matrix reduces therisk of rejection and inflammation and the matrix provides a basis forsoft tissue reconstruction. Such an acellular human matrix is availablefrom Lifecell (Branchburg, N.J.) and is referred to as AlloDerm®acellular tissue.

Oriented materials suitable for use in the present invention includehuman fascia lata and rectus fascia. Cleaned and sterilized orientedhuman tissue materials may be obtained from tissue banks. Suitableanimal tissues may be suitable for use in accordance with the inventionafter the animal tissues are cleaned, chemically treated, and sterilizedaccording to various methods that are available in the art. Such animaltissues may be available from government regulated slaughterhouses, forexample.

Suitable synthetic materials may be a solid material, a weave, a braid,a mesh or an alternate material construction. The synthetic material maybe a polymer. Suitable polymer sources may include nylon, polyethylene,polyester, polypropylene, fluoropolymers or copolymers thereof. Anexemplary synthetic polyester material suitable for use in according tothe invention is available under the trade designation Dacron®, from E.I. du Pont de Nemours and Company (Wilmington, Del.). Other suitablesynthetic materials include the fluoropolymers available under the tradedesignation Teflon®, from E. I. du Pont de Nemours and Company(Wilmington, Del.). Suitable absorbable synthetic materials may beemployed in accordance with the invention. Such absorbable syntheticmaterials include polyglycolic acid (PGA), polylactic acid (PLA), andother available absorbable synthetic materials. A PGA material that maybe suitable for use in accordance with the invention is available underthe trade designation Dexon®, from Davis and Geck (Wayne, N.J.). Othersuitable polymeric and non-polymeric synthetic materials may be employedin accordance with the invention.

Combinations of synthetic materials and mammalian tissues may also beused according to the invention. These combinations may include materialhaving a combination of parts, including, for example, parts made ofsynthetic polymers and of processed animal tissues. Such combinationsalso include materials that include both synthetic polymers and animalcells that are treated so as to cross-link the collagen or othercommonly antigenic fibers in the animal cells.

The sheet 6 is provided in a shape suitable for a medical application.Suitable shapes of sheets 6 may be rectangular and substantiallyrectangular. The material may be shaped such that elongated membersextend from a central portion of the sheet 6. Other suitable shapes ofthe sheet 6 include octagonal, trapezoidal, elliptical and hexagonalshapes.

A second step of making the sling 2 is forming one or more cuts 10 inthe sheet 6 positioned substantially along at least a portion of thematerial's 6 perpendicular axis 38. The cuts 10 are disposed so thatupon exposure to tensioning force applied substantially along thelongitudinal axis 34 of the sheet 6, pursuant to a medical application,the distance 150 remains substantially constant. Multiple cuts 10 mayall be formed at the same time. Alternatively, cuts 10 can be formed oneat a time. A cut 10 may be formed by extending a straight blade edgethrough the sheet 6 for the length of the cut 10. The cuts 10 may alsobe formed by pressing a die in the shape of cut 10 into the sheet 6 topunch out and separate the shape of the punched cut 10 from the sheet 6.For example, a sharpened die in the shape of aperture 10B pressed intosheet 6 will form the aperture 10B in the sheet 6 by punching out andseparating the shape of aperture 10B from the sheet 6. Other methods maybe employed to form cut(s) in the sheet 6.

In some embodiments, exposing the cuts 10 to heat when forming the cuts10 or after they are formed in the sheet 6 seals the cuts 10 andprevents the sheet 6 from fraying at the site of each cut 10. Heatsealing the sheet 6 at the site of the cuts 10 may be useful when, forexample, the sheet 6 is a synthetic polymer material of solid, woven,braided, mesh or other construction.

The cuts 10 may be sealed ultrasonically, by exposing the cuts 10 tomechanical heat to seal the cuts 10. Alternatively, the cut 10 may be aslit 10A that is made with a straight blade edge that is heated to asufficient temperature to seal the slit 10A. In one particularembodiment, a sharpened die in the shape of aperture 10B is heated andthe aperture 10B is cut and sealed in one step by pressing the heateddie into sheet 6 to punch out and form a sealed aperture 10B in thesheet 6.

In one embodiment, one or more of the cuts 10 are slits 10A that extendthrough the thickness of the sheet 6 for the length of the slit 10A.Alternatively, for example, the slits 10A do not extend through theentire thickness of the material for the length of the slit 10A.However, upon exposure to tensioning force applied during theimplantation, the slit 10A may extend through the sheet 6 to provideopen surface area through the material. In another embodiment, asdisclosed in FIG. 3, one or more of the cuts 10 is an aperture 10B. Uponexposure to tensioning force applied during the medical application, oneor more of the apertures 10B remain open.

An alternative embodiment, as shown in FIG. 4, includes the step offorming a line 42 substantially along at least a portion of theperpendicular axis 38 of the sheet 6. The line 42 may be formed by, forexample, applying surgical ink along the perpendicular axis 38 of thesheet 6.

Another embodiment, as disclosed in FIG. 5, includes the step ofdisposing one or more fasteners 46 at the first end portion 14 of thesheet 6. Thereafter, one or more fasteners 46 may be disposed at thesecond end portion 24 of the sheet 6. Fasteners 46 disposed on the sling2 include sutures, bone anchors, staples, clips, and other suitablefasteners. In one particular embodiment, the fasteners 46 are suturesthreaded through and secured to the sheet 6 at locations where slits 10Aare not present for the first and last 1 cm of the longitudinal axis 34.

In an alternative embodiment, as shown in FIG. 2, one or more eyelets 48are formed in the sheet 6 and the fasteners 46 are sutures threadedthrough and secured to the eyelets 48. The eyelets 48 may be formedthrough the material by pressing a die in the shape of the eyelet 48into the material and punching the shape of the eyelet 48 out of thesheet 6. In one particular embodiment, the sheet 6 is a syntheticbraided material and a heated die in the shape of eyelet 48 is pressedinto the sheet 6 to form the sealed eyelet 48, thus preventing the sheet6 from fraying at the site of the eyelet 48.

The sling 2 may be sterilized and packaged in a sterile holder. Thepackaging conditions may be dry and the package protective of the sling2 during transport and storage. The packaging may be designed to protectthe sheet 6 of the sling 2 from ultra-violet light to prevent damage.The sling 2 disclosed herein is packaged in a shape and size suitablefor its intended purpose. Upon opening the protective package, the sling2 may be hydrated, if necessary, with, for example, saline solution, andthereafter implanted in the patient without any additional alteration bythe surgeon performing the surgical procedure. In an embodiment where,for example, the sling 2 made of mammalian tissue material is employed,the sling 2 is hydrated in saline solution prior to implantation.

In one embodiment, in accordance with the invention, a method oftreating a damaged portion of a patient's body employs the sling 2. Themethod includes, in overview, providing the sling 2, as describedherein. Securing the first end portion 14 of the sheet 6 of the sling 2to a first anatomical structure in the body of the patient. Applyingtensioning force substantially along the longitudinal axis 34 of thesheet 6. Securing the second end portion 24 of the sheet 6 to a secondanatomical structure in the body of the patient. The perpendicular axis38 of sling 2 is positioned so that it lies substantially along aportion of the patient's body. The one or more cuts 10 disposed alongthe perpendicular axis 38 are disposed such that the distance 150remains substantially constant with the sheet 6 secured. Supporting adamaged portion of the patient's body with the secured sheet 6. In someembodiments, the sheet 6 evenly distributes pressure on a damagedportion of a patient's body. Alternatively, the sling may be secured inan anchorless manner, in which the structure of sling (i.e., tangedportions provides resistance against movement of the sling in the tissuewhile tissue in growth occurs, without the use of an independentanchoring structure.

In one particular embodiment, the sling is employed to treat a femalepatient suffering from stress urinary incontinence. Physiologicalconditions that cause stress urinary incontinence include ISD,bladderneck hypermobility, and a combination of the two conditions. Whena sling is employed to treat these conditions, it may be used to providesupport to the patient's urethra. Where the physiological condition isISD, the sling may be implanted to improve improper coaption of theurethral sphincter. Alternatively, where the condition is hypermobility,the sling may be implanted to support, elevate or “back stop” themidurethra. In the patient who suffers from a combination of ISD andhypermobility, a sling 2 may be implanted to support one or both ofthese sites.

Methods of sling delivery and implantation to treat female stressincontinence include transvaginal, transabdominal, supra-pubic,pre-pubic, and transobturator approaches, or some combination of theseprocedures. Preoperatively, according to these sling delivery methods,the patient receives broad spectrum antibiotics, such as gentamicin andampicillin. The patient is placed in the dorsal lithotomy position andregional or general anesthesia is administered. Preparation of thepatient may include isolation of the anus with a stapled towel orplastic drape. A Foley catheter is placed.

In the transvaginal method, a midline incision is made in the uppervaginal wall beneath the bladdemeck, such as at the urethro-vesicaljunction. Starting adjacent to the bladder neck on either side of theurethra, a 1 cm incision is made through the anterior vaginal wallapproximately 1 cm lateral to and parallel to the midline of theurethra. The vaginal wall is retracted to allow access to the endopelvicfascia. The surgeon then inserts an instrument such as surgical scissorsthrough the incision in the upper vaginal wall and bluntly dissects thetissue on both sides of the urethra to create a pocket for the sling.

The pocket can also be created and the sling can be inserted using avariety of other minimally invasive instruments/methods including thetransvaginal, hiatal and percutaneous approaches disclosed in U.S. Pat.No. 6,053,935 entitled “Transvaginal Anchor Implantation Device” issuedApr. 25, 2000, U.S. patent application Ser. No. 09/023,965 entitled“Percutaneous and Hiatal Devices and Methods for Use in MinimallyInvasive Pelvic Surgery” filed Feb. 13, 1997, and U.S. Pat. No.6,099,547 entitled “Method and Apparatus for Minimally Invasive PelvicSurgery” issued Aug. 8, 2000, which are incorporated herein byreference.

In one embodiment, the sling is secured to the pubic bone with a sutureattached to a bone anchor. Referring to FIG. 8A, the sling 2 isimplanted inside the patient and the first end portion 14 and the secondend portion 24 of the sheet 6 are secured to the pubic bone 230. Thesling 2 is similar to the sling described above and shown in FIG. 4. Thesling 2 is a rectangular sling made of mammalian material, with a line42, a visual indicator, disposed along the perpendicular axis 38. Theslits 10A are disposed along the line 42. The sling 2 may be positionedbetween the urethra 210 and the exterior of the anterior vaginal wall200. According to the anatomical defects of the patient and thepreference of the physician, the placement of the sling 2 supports,elevates, or provides a “backstop” for the urethra 210. A variety ofinstruments/methods may be used to secure the sling 2 to the bone 230including the bone anchor disclosed in the U.S. Pat. No. 6,053,935entitled “Transvaginal Anchor Implantation Device,” issued Apr. 25,2000, the disclosure of which is hereby incorporated by reference.

An anchor implantation device is introduced through the opening in thevaginal wall 200. The leading edge of the anchor implantation device ispressed through the anterior vaginal wall incision to the side of thebladder neck, and inserted into the inferior edge of the posterioraspect of the pubic bone. In some embodiments, the anchor implant siteis located lateral to the symphysis pubis and cephalad to the inferioredge of the pubic bone. In one particular embodiment, the anchor implantsite is located approximately 1 cm lateral to the symphysis pubis and 1cm cephalad to the inferior edge of the posterior aspect of the pubicbone.

After the anchor is driven into the pubic bone 230, the anchorimplantation device is withdrawn and removed leaving the two free endsof suture exiting the endopelvic fascia and trailing the two free endsof the suture from the vaginal wall 200 incision. The above procedure isrepeated on the opposite side of the urethra 210 to implant a secondanchor.

A pre-sized sling 2 may be selected to suit the size of the patient. Thesling 2 is removed from its sterile packaging. In some embodiments, thesurgeon will remove excess portions of the sling 2 to suit the patient.In an embodiment where the sheet 6 is made from mammalian tissue, thesurgeon may cut off excess portions of the sling 2 without furthertreatment of the sheet 6 to prevent fraying. In embodiments where thesheet 6 is made from a synthetic material, the surgeon may heat seal theedge where excess sheet 6 was removed from the sling 2 to prevent thematerial from fraying. Thereafter, the sling 2 is hydrated inpreparation for implantation. Water, saline, or other solutions may beemployed to hydrate the sling. Furthermore, the hydrating solution mayinclude an antimicrobial and/or an antibiotic.

The sling 2 is positioned in the pocket formed under the urethra 210.The free ends of suture from the two anchors on each side of the urethra210 are then tied to the first end portion 14 and the second end portion24 of the sling 2. The sutures are then tied off with the appropriateamount of tension to support the urethra 210. In one particularembodiment, slits 10A are disposed about line 42 on sling 2 and line 42is aligned with the portion of the patient's urethra 210 requiringsupport. Upon implantation, at least some of the slits 10A will provideopen areas to patient's urethra. The vaginal wall 200 incision is thenclosed.

In an alternative transvaginal procedure, the sling is implanted insidethe patient as depicted in FIG. 8B. The sling 2 is similar to the sling2 described above and shown in FIG. 4. The sling 2 is rectangular inshape and is comprised of mammalian tissue. The sling has both a visualindication line 42 and slits 10A disposed along the perpendicular axis38. The sling 2 is implanted inside the patient and the first endportion 14 and the second end portion 24 of the sheet 6 are secured tothe muscular and/or fascial urethral supports 220. The sling 2 islocated between the urethra 210 and the exterior of the anterior vaginalwall 200. The sling 2 supports the urethra 210.

The pocket is formed as described above. The sling 2 size may bepre-selected to suit the patient. The surgeon selects the sling sizeaccording to the patient size and area the sling 2 is employed tosupport. The sling 2 is removed from the sterile packaging, any excessportions of the sling 2 are cut off to suit the patient and, ifnecessary, the sling 2 is sealed to prevent fraying where portions ofsheet 6 were removed from the sling 2. Thereafter, water, saline, anantimicrobial and/or an antibiotic solution, or other solutions areemployed to hydrate the sling 2 in preparation for implantation.

A suture is attached to the first end portion 14 of the sling 2. Thesuture is threaded through a surgical needle and is introduced insidethe patient's body through the opening in the vaginal wall 200. Thesurgical needle and suture are pressed through the muscular and fascialurethral support 220. The suture anchors the sling 2 to the muscular andfascial urethral support 220. Once the first end portion 14 of sling 2is anchored to the anatomical structure, the needle is detached from thesuture. The surgeon then applies tension to the sling 2 and visuallyaligns line 42, thereby aligning the slits 10A, with the portion of thepatient's urethra requiring support. Thereafter, the above procedure isrepeated on the opposite side of the urethra 210 to anchor the secondend portion 24 of sling 2 to the muscular and/or fascial urethralsupport 220. The surgeon confirms that an appropriate level of tensionis applied to the sling 2 to support the patient's urethra. Some or allof the slits 10A will provide open areas to the patient's urethra uponimplantation inside the patient's body. The vaginal wall 200 incision isthen closed.

In alternative embodiments, the sling is secured to the body of thepatient without the use of anchors. In a particular embodiment, thesling is delivered and implanted through a transvaginal procedure. Atrack is formed through abdominal incisions behind the pubic bone to thevagina. The sling is introduced laterally along the track and on eitherside of the mid-urethra. In another embodiment, the sling is deliveredand implanted through a supra-pubic procedure. The track is formedthrough abdominal incisions behind the pubic bone to the vagina. Theends of the sling are drawn back up through the track to place the slinglooped underneath the mid-urethra. In yet another embodiment, the slingis delivered and implanted through a pre-pubic procedure. In thisprocedure, the track is formed in front of the pubic bone. The ends ofthe sling are drawn back up through the track to place the sling loopedunderneath the mid-urethra. In yet another embodiment, the sling isdelivered and implanted through a trans-obturator procedure. The trackis formed from each of the obturator foramen to the vagina. The sling isdrawn back through the tracks from the vagina, forming a shallow loop orhammock underneath the urethra.

In an alternative embodiment, the sling 2 is secured to the body of thepatient with a sutureless fastener. Exemplary fasteners that may be usedinclude staples, bone anchors and clips. In another embodiment, theslings shown in FIGS. 1, 2, 3, 4, 5, 6A, 6B, 7A, 7B, 8A and 8B can besecured to the body of the patient using a number of fasteners thatinclude sutures, clips, bone anchors and staples.

The placement of sling 2 relative to the urethra varies according to thecondition being treated. Where the condition being treated isbladderneck hypermobility, the sling may be implanted to support,elevate or “back stop” the midurethra and the distal urethra. The slingmay be implanted to stabilize or kink the urethra and improve urethralclosing pressure, thereby improving continence.

Generally, the implanted distance 150 of slings 2 disposed with slits10A will reduce by between about zero and about twenty percent. Thepercentage by which the distance 150 reduces upon exposure to surgicaltensioning force will depend on the number of slits 10A and the materialtype 6, whether from mammalian tissue, synthetic material, or acombination of mammalian tissue and synthetic material. The placement ofthe slits 10A on the material will also impact the percentage by whichthe distance 150 may reduce. When, for example, the slits are formedalong the grain of an oriented mammalian tissue or along the hightensile strength direction of a synthetic material, the distance 150 maybe reduced by a lower percentage then if an omnidirectional tissuematerial or a synthetic with equivalent tensile strength at alldirections were employed.

FIGS. 9A–9C each provide a sagittal section of a female pelvisillustrating one location of the sling 2 relative to the mid-urethra anddistal urethra and anchored to the pubic bone 230. In some embodiments,the sling is positioned mid-urethrally to treat hypermobility.

In FIG. 9A, the sling 2 is anchored to the inferior edge of the publicbone 230. The sling 2 may be implanted via the transvaginal proceduredescribed above and shown in FIG. 8A. As shown in FIG. 9B, the sling 2may also be anchored between the superior and inferior edge of theposterior aspect of the pubic bone 230 at the mid-point or lower towardthe inferior edge of the pubic bone 230. The sling 2 may also beimplanted via the above referenced transvaginal procedure shown in FIG.8A.

As shown in FIG. 9C, the sling 2 may be anchored to the anterior side ofthe superior end of the pubic bone 230. In some embodiments the sling isanchored to the pubic tubercles. The sling 2 may be implanted byemploying a percutaneous approach to anchor the sling in the positionshown in, for example, FIG. 9C.

The sling of FIGS. 9A–9C is similar to the sling 2 of FIG. 4. In oneparticular embodiment, the sling 2 depicted in FIG. 4 is made ofomnidirectional mammalian tissue material with slits 10A disposedtherethrough and the unimplanted distance 150 of the sling 2 is about 2cm. During implantation, the sling 2 is exposed to substantiallylongitudinal tensioning force. When implanted, the sling 2 distance 150will reduce by about twenty percent and the implanted sling will have adistance 150 of about 1.6 cm, thereby maintaining a substantiallyconstant distance upon exposure to substantially longitudinal tensioningforce applied to the sheet 6 during the medical application.

In one particular embodiment, the slits 10A are disposed about the line42 on sling 2. The line 42 is employed to visually align the sling 2with the patient's midurethra and distal urethra. In one embodiment, thesheet 6 of sling 2 evenly distributes pressure on the urethra. Inanother embodiment, the sling 2 evenly distributes pressure on themidurethra without applying pressure to other portions of the urethra.

Upon implantation inside the patient, some or all of the slits 10Aprovide open areas to the mid-urethra and distal urethra. Some of theslits 10A may become open when the slits 10A are bent around to surroundthe patient's urethra during implantation. Very soon thereafter, cellsinfiltrate the open areas of the sling 2 and tissue growth begins. Thetissue on both sides of the sling 2 cross communicates such that tissuefrom both the anterior vaginal wall 200 and urethra 210 grows into theopen areas on the sling 2 that they surround. This scar tissue growthprovides support to the portions of the mid-urethra and the distalurethra adjacent to the open areas. This tissue growth also secures thesling 2 at the site of implantation, thus improving urethra closingpressure and patient continence.

Within a few weeks of implantation, the area where the slits 10A are onsling 2 made of mammalian tissue material will be absorbed into theportion of the patient's body adjacent to the slits 10A. The time periodrequired for the entire sling 2 made from mammalian tissue material tobe absorbed by the patient's body may be reduced in proportion to theopen surface area on the sling 2. Thus, where slits 10A provide theimplanted sling 2 with fifty percent open surface area, then the timeperiod for the sling 2 to be absorbed into the patient's body may bereduced to between about three and twelve months compared to the minimumsix months for mammalian tissue material lacking any cuts. The sling 2embodied FIG. 4 may be absorbed by the patient's body within a period ofbetween about five and about twelve months.

In some embodiments, where the condition being treated is ISD, the slingmay be implanted to support the distal bladder neck, the sphinctermuscle, and the urethra in order to improve improper coaption of theurethral sphincter. FIG. 10 is a sagittal section of a female pelvisillustrating the location of the sling relative to the bladdemeck,sphincter (not shown), and the urethra and anchored to the pubic bone230. The sling 2 is implanted to treat ISD. The sling 2 of FIG. 10 maybe implanted via the transvaginal procedure shown in FIG. 8A. In thetreatment of ISD the sling applies direct pressure to the urethra.

The sling of FIG. 10 is similar to the sling 2 described above and shownin FIG. 3, where the sling 2 is disposed with apertures 10B. Generally,the implanted distance 150 of the sling 2 disposed with apertures 10Bwill reduce by between about zero and about fifty percent. Thepercentage by which the distance 150 reduces upon exposure to surgicaltensioning force will depend on the number of apertures 10B and the typeof sheet 6, whether from mammalian tissue, synthetic material, or acombination of mammalian tissue and synthetic material. The size of theapertures 10B and their placement on the sheet 6 will also impact thepercentage by which the distance 150 may reduce. When, for example, theapertures 10B are formed along the grain of an oriented mammalian tissueor along the high tensile strength direction of a synthetic material,the distance 150 may be reduced by a lower percentage then if anomnidirectional tissue material or a synthetic with equivalent tensilestrength at all directions were employed.

In one embodiment the sling 2 depicted in FIG. 3 the sling 2 is made of,for example, omnidirectional mammalian tissue material with apertures10B disposed therethrough. The unimplanted distance 150 of sling 2 isabout 2 cm. During implantation, the sling 2 is exposed to substantiallylongitudinal tensioning force. When implanted, as shown in FIG. 10, thesling 2 will have a distance 150 of about 1.2 cm, thereby maintaining asubstantially constant distance upon exposure to substantiallylongitudinal tensioning force applied to the sheet 6 during the medicalapplication.

The distance 150 of the sling 2 made of omnidirectional mammalian tissuesheet 6 depicted in FIGS. 10 and 3 may be reduced by a higher percentagethan the sling 2 depicted in FIGS. 9A–9C and 4 made of a sheet 6 of thesame material. The distance 150 of sling 2, shown in FIG. 3, may bereduced by a higher percentage because the apertures 10B create agreater open surface area. The apertures 10B may result in morestretching of sheet 6 in the longitudinal direction reducing thedistance 150 more then the open surface area of the slits 10A, shown inFIG. 4.

The apertures 10B are disposed about the line 42 on sling 2. The line 42is visually aligned with the patient's bladdemeck, sphincter muscle, andurethra. In one embodiment, the midpoint of the perpendicular axis 38distance 150 is located adjacent to the urethral sphincter muscle, thefirst side 18 is adjacent to the distal bladdemeck, and the second side28 is adjacent to the urethra. In one embodiment, the sheet 6 of sling 2evenly distributes pressure on the patient's bladdemeck, sphinctermuscle, and urethra. In another embodiment, the sheet 6 evenlydistributes pressure on the sphincter muscle alone without applyingpressure to the bladderneck and urethra.

Upon implantation, some or all of the apertures 10B maintain an opensurface area. Very soon after implantation, tissue begins to grow intothe open areas on the sling 2. The tissue on both sides of the sling 2cross communicates, whereby the tissues from the anterior vaginal wall200 and urethra 210 and bladderneck grow into the open areas. Thistissue growth provides support to urethral sphincter muscle, urethra,and bladdemeck adjacent to the open areas. This tissue in-growth alsosecures the sling 2 at the site of implantation. The tissue in-growthwill improve coaption of the urethral sphincter, which will improvepatient continence.

In an embodiment where the sling 2 is made of mammalian tissue, the areawhere the apertures 10B provide open areas on the sling 2 will belocally absorbed into the body of the patient, into the urethralsphincter muscle, urethra, and bladderneck, within a few weeks afterimplantation. The time period required for the sling 2 to be absorbed bythe patient's body may be reduced in proportion to the open surface areaon the sling 2 provided by the apertures 10B disposed through the sling2. Thus, if fifty percent of the sling 2 provides open surface area whenimplanted inside the patient's body the time period to absorb may bereduced to between about three months and about twelve months. The sling2 shown in FIG. 3 that is made from mammalian tissue sheet 6 may beabsorbed by the patient's body within a period of between about four andabout twelve months.

In the combination transvaginal and transabdominal method, the sling isintroduced transvaginally, through insertion into pocket through theupper vaginal wall, as described above. Either before or after creatingthe pocket, an anchor is introduced into the pubic bone 230 for fixationof suspensory sutures, with or without predrilling a hole in the pubicbone. For instance, the anchor is introduced using an anchorimplantation device of a type such as that illustrated in FIGS. 15–19 ofU.S. Pat. No, 5,766,221, entitled “Bone Anchor Implantation Device”,issued Jun. 16, 1998, which is incorporated herein by reference. Anchorsites are located by placing the anchor implantation device on the bodyover the area of the pubic bone after visualization or digital palpationover the bone. The surgeon then extends the bone probes distally untilboth probes have made contact with the pubic bone. One or more anchorsare implanted into the tubercle portions of the pubic bone at each sideof the urethra. The anchor preferably has a suture secured thereto priorto implantation of the anchor into the pubic bone so that a first sutureend and a second suture end extend from the implanted anchor afterremoval of the anchor driver.

The surgeon selects the sling 2. The above described sling 2 comprisessheet 6 disposed with cuts 10 substantially along at least a portion ofthe perpendicular axis 38. In some embodiments, the sling 2 has a line42 disposed substantially along at least a portion of the perpendicularaxis 38.

An incision is made in the anterior vaginal wall and a pocket is formedas described above. A suture passer is introduced inside the patient'sbody through the opening in the vaginal wall. Thereafter, the surgeonattaches the sutures to the sling 2. In alternative embodiments, thesutures are pre-attached to the sling 2 of the invention. This step isunnecessary in embodiments were a suture is pre-attached to the sling 2of the invention, as in FIG. 5, and in sutureless embodiments. Aftersecuring the sutures to the sling, the first end of the suture iscaptured by the suture passer and passed through the body.

In one embodiment, the one or more of the sutures can be laterallyattached to anatomical support structures other than the pubic bone, forexample, the ileal pectineal ligament (termed Cooper's ligament), thearcus tendinous fascia pelvis, or the pubococcygenous muscle complex. Inone particular embodiment, the first end portion 14 of the sling 2 issecured to the pubic bone and the second end portion 24 is attached tothe arcus tendinous fascia pelvis (termed the White Line).

In order to minimize postoperative urinary blockage caused by excessivetension, suture tension is regulated by tying the first and second endsof the sutures across a suture tensioner of a type, for example,illustrated in and described with respect to FIGS. 46–49 of U.S. Pat.No. 5,611,515 entitled “Bladderneck Suspension Procedure”, issued Mar.19, 1997, and the U.S. patent application Ser. No. 09/184,468 entitled“Transvaginal Suture Spacer Devices and Methods of Use”, filed Nov. 2,1998 (both of which are incorporated herein by reference). The suturetensioner is thereafter removed and the position of the sling 2 isreconfirmed prior to closing the vaginal and suprapubic wounds.Transabdominal surgical methods may also be employed to implant thesling 2 in accordance with the invention.

In one embodiment of the invention, non-synthetic material is attachedto or wrapped around at least a portion of the synthetic mesh to formthe structure of the sling. The non-synthetic material may wrap aroundat least a portion of the sheet. The non-synthetic material may alsocompletely encompass at least a portion of the sheet. In variousembodiments, the non-synthetic material is free floating about thesheet.

When placed within the body of a patient, the non-synthetic material maybe disposed adjacent to the urethra. In another embodiment, thenon-synthetic material extends to each side of an endopelvic fascia whenthe sling is placed within the body.

By combining a synthetic material with a non-synthetic material, erosionof body tissue is reduced or eliminated. Without wishing to be bound toa particular theory, it is believed that the interaction of thesynthetic material comprising the sling with body tissue may causeerosion into the body. In particular, it has been observed thatsynthetic polymers may cause erosion into the urethra and vagina. Theincorporation of a non-synthetic material, for example, REPLIFORM®Tissue Regeneration Matrix or other suitable animal sources of tissue,into the sling, preferably in the center of the sling, may reduceerosion. Moreover, the non-synthetic material, once placed within thebody, will promote fibroblast development of normal body tissue andtissue in-growth. The slings shown in FIGS. 11–20 include anon-synthetic material attached to or wrapped around a synthetic meshmaterial. These figures depict numerous manners by which to attach to orwrap the non-synthetic material around the mesh; however, the inventionenvisions other methods of attaching the matrix to the mesh.

FIGS. 11A and 11B depict an embodiment of a sling 320 in accordance withthe invention. As shown, the non-synthetic material 310 wraps around aportion of a length and a width of the mesh sheet 300. In oneembodiment, the non-synthetic material 310 is crimped along onelength-wise end 315. Alternatively, the non-synthetic material 310 couldbe crimped on both ends. The non-synthetic material 310 is free floatingabout the sheet 300, because the non-synthetic material 310 is notattached to the sheet 300, but to itself.

FIGS. 12A and 12B depict an alternative embodiment of a sling 420 inaccordance with the invention. In FIG. 12A, a non-synthetic material 410is connected to one side of a portion of a mesh sheet 400. FIG. 12Bshows a side view of a portion of the sling 420 from FIG. 12A. Thenon-synthetic material 410 can be attached to the sheet 400 by, e.g.,glue, sutures, staples, clips, etc. The sheet 400 extends the entirelength of the sling 420.

FIGS. 13A and 13B illustrate an alternative embodiment of a sling 520,wherein two separate pieces of non-synthetic material 510 are attachedto both a top surface 505 and a bottom surface 506 of a portion of amesh sheet 500.

FIG. 14 depicts yet another embodiment of a sling 620 in accordance withthe invention. In FIG. 14, two separate pieces of mesh sheets 600, 601are glued to opposite ends of a non-synthetic material 610.

FIGS. 15–18 are structurally similar to the sling 620 of FIG. 14. InFIG. 15, anon-synthetic material 710 is attached to mesh sheets 700, 701by sutures 725. In FIG. 16, a non-synthetic material 810 is attached tomesh sheets 800, 801 by staples 830. In FIG. 17, a non-syntheticmaterial 910 is attached to mesh sheets 900, 901 by rivets 935. In FIG.18, a non-synthetic material 1010 is attached to mesh sheets 1000, 1001by clips 1040.

FIGS. 19A and 19B depict yet another embodiment of a sling 1120 inaccordance with the invention. In FIGS. 19A and 19B, a non-syntheticmaterial 1110 wraps around a portion of a mesh sheet 1100 so as toenclose the width-wise ends of a portion of the sheet 1100. In thisembodiment, the sheet 1100 extends an entire length of the sling 1120and the non-synthetic material 1110 is free floating about the sheet1100. Alternatively, the non-synthetic material 1110 can be secured tothe sheet 1100 by any of the methods disclosed herein.

FIG. 20 depicts another embodiment of a sling 1220 in accordance withthe invention. In FIG. 20, a non-synthetic material 1210 is disposedadjacent to a mesh sheet 1200. Slits 1215 are disposed along a secondaxis 1238 of the non-synthetic material 1210.

In various embodiments, the sling may be pre-soaked in a prescribed drugprior to implantation in a patient's body. Exemplary drugs includeneomycin, antimicrobials, and antibiotics, generally. In someembodiments, the hydrophilic material, the drug, or both, when used incombination, release the drug to the patient tissues upon contact. Thus,the drugs that are delivered to the patient tissue surfaces whenaccessing and inserting the sling are active upon contact with thepatient's tissue during implantation of the surgical device.

Similarly, a hydrophobic coating may be employed on one or more surfacesof the sling. Suitable hydrophobic coatings include, but are not limitedto, polytetrafluoroethylene, silicon, and Pyrelene. Such hydrophobiccoatings may be used in conjunction with and absorb hydrophobic drugs.Suitable hydrophobic drugs include, but are not limited to, ibuprofen,ketoprofen, diclofenac, and lidocaine in hydrophilic form. Where thebonding between these coatings and drugs is weak, the drug that isabsorbed will readily release to be delivered to the surfaces itcontacts. Alternatively, a stronger bonding affinity may provide aslower timed release of the drug.

The slings disclosed herein are designed to be secured to any suitablesupport structure of a patient's body. Examples of such structuresinclude but are not limited to the bones, ligaments, fascia, andappropriate muscle structures proximate to the site of attachment. Forexample, sutures may be used to attach the sling to the Cooper'sligament or the rectus fascia without using a bone anchor.Alternatively, the slings disclosed herein may be secured in ananchorless manner, by any one or more of the approaches described above,in which the structure of the sling (i.e., tanged portions) providesresistance against movement of the sling in the tissue while tissue ingrowth occurs.

Having thus described certain embodiments of the present invention,various alterations, modifications, and improvements will be apparent tothose of ordinary skill. Such alterations, modifications, andimprovements are within the spirit and scope of the invention, and theforegoing description of certain embodiments is not exhaustive orlimiting.

1. A sling for treating urinary incontinence, comprising: a firstimplantable sheet sized and shaped to fit under and for supporting aurethra of a patient, the first sheet comprising a synthetic materialhaving a width of between about 1 cm and about 3 cm and a length ofbetween about 1 cm and about 30 cm, having first and second ends, andhaving upper and lower sides, a first mammalian tissue material attachedto the upper side of the first sheet between the first and second endsspanning substantially the entire width of the first sheet and at leasta portion of the length of the first sheet, for being interdisposedbetween the upper side of the first sheet and the urethra, theattachment being by at least one of glue, suture, stable, rivet, eyeletrivet, and clip, and a second mammalian tissue material attached to thelower side of the first implantable sheet opposite the first mammaliantissue material, the attachment being by at least one of glue, suture,staple, rivet, and clip.
 2. The sling of claim 1 wherein the firstmammalian tissue material is disposed adjacent to a urethra when placedwithin a body of a patient.
 3. The sling of claim 1 wherein the firstmammalian tissue material can extend to each side of an endopelvicfascia when placed within a body of a patient.
 4. The sling of claim 1wherein the first mammalian tissue material comprises an acellularmatrix processed from human or bovine dermis.
 5. The sling of claim 1wherein the first mammalian tissue is capable of remodeling into ahealthy layer of tissue.
 6. The sling of claim 1 wherein at least aportion of the first implantable sheet is tanged.
 7. The sling of claim1 wherein the first implantable sheet comprises fibers selected from thegroup consisting of colored, radiopaque, and combinations thereof. 8.The sling of claim 1 wherein the first implantable sheet is of a typeselected from the group consisting of woven, knitted, felted, andcombinations thereof.
 9. The sling of claim 1 wherein the sheetcomprises a coating.
 10. The sling of claim 9 wherein the coatingcomprises a pharmaceutical for delivery to a patient when the sling isimplanted in a body of the patient.
 11. The sling of claim 1 wherein thesynthetic material is at least one material selected from the groupconsisting of nylon, polyethylene, polyester, polypropylene, andfluoropolymers.
 12. The sling of claim 1 wherein the first mammaliantissue material is about 4 cm to about 10 cm in length along the firstaxis of the sheet.
 13. The sling of claim 1 wherein the first mammaliantissue material is selected from the group consisting of bovine,porcine, ovine, equine, human cadaveric, and tissue-engineered tissues.14. The sling of claim 1 wherein the first mammalian tissue materialincludes one or more slits.
 15. The sling of claim 14 wherein at leastone of the one or more slits opens upon exposure to a tensioning forceapplied during a medical application.
 16. The sling of claim 14 whereineach of the slits comprises an aperture.
 17. The sling of claim 16wherein at least some of the apertures remain open after exposure to atensioning force applied during a medical application.
 18. A method ofmaking a sling for treating urinary incontinence, comprising: providinga first implantable sheet suitable for treating urinary incontinence,and sized and shaped to fit under and for supporting a urethra of apatient, the first sheet comprising a synthetic material having a widthof between about 1 cm and about 3 cm and a length of between about 1 andabout 30 cm, having first and second ends, and having upper and lowersides, attaching first mammalian tissue material to the upper side ofthe first sheet between the first and second ends, the first mammaliantissue material spanning substantially the entire width of the firstsheet and at least a portion of the length of the first implantablesheet, for being interdisposed between the upper side of the first sheetand the urethra, the attachment being by at least one of glue, suture,staple, rivet, eyelet rivet, and clip, and attaching a second mammaliantissue material attached to the lower side of the first implantablesheet opposite the first mammalian tissue material, the attachment beingby at least one of glue, suture, staple, rivet, eyelet rivet, and clip.